Lundbeck starts clinical phase IIa with Lu AA24493 (cEPO) in Friedreich's ataxia in a study also assessing efficacy via biomarkers

H. Lundbeck A/S strengthens its pipeline of pharmaceuticals in
clinical development by initiating phase IIa clinical studies with
the innovative project Lu AA24493 in order to evaluate safety and
tolerability and to explore theoretical efficacy parameters of the
drug in humans. Lundbeck expects to enrol 35-40 people suffering from
Friedreich's ataxia in this study.

Lu AA24493 is a novel carbamoylated form of human erythropoietin
(EPO) - a modification of EPO that results in loss of haematopoietic
effects but maintains the tissue protective effect. These tissue
protective effects translate to very positive effects in a number of
animal models for neuronal damage

The primary objective of the study is to evaluate the safety and
tolerability of two weeks treatment with a fixed dose Lu AA24493 in
patients with Friedreich's ataxia. However, this placebo-controlled
programme may also potentially provide efficacy signals via
biomarkers.

"This project in Friedreich's ataxia represents Lundbeck's focus to
discover and develop innovative compounds that address unmet needs
for patients. Lu AA24493 is an example of compounds with a great
potential for addressing a small but very severe disease," says
Executive Vice President Anders Gersel Pedersen, Head of Drug
Development at Lundbeck. "Furthermore, this project represents an
innovative process in obtaining proof of principle as we look for
signals related to a biomarker as an early indicator of drug
activity".

About Friedreich's ataxia[1]
Friedreich's ataxia is an inherited disease that causes progressive
damage to the nervous system resulting in symptoms ranging from gait
disturbance and speech problems to heart disease. It is named after
the physician Nicholaus Friedreich, who first described the condition
in the 1860s. "Ataxia," which refers to coordination problems such as
clumsy or awkward movements and unsteadiness, occurs in many
different diseases and conditions. The ataxia of Friedreich's ataxia
results from the degeneration of nerve tissue in the spinal cord and
of nerves that control muscle movement in the arms and legs. The
spinal cord becomes thinner and nerve cells lose some of their myelin
sheath - the insular covering on all nerve cells that helps conduct
nerve impulses.

Friedreich's ataxia, although rare, is the most prevalent inherited
ataxia, affecting about 1 in every 50,000 people in the Caucasian
population. Males and females are affected equally.

As with many degenerative diseases of the nervous system, there is
currently no cure or effective treatment for Friedreich's ataxia.
However, many of the symptoms and accompanying complications can be
treated to help patients maintain optimal functioning as long as
possible.

About Lu AA24493
Lu AA24493 is a novel cytoprotective compound currently in
development for acute ischaemic stroke. It is chemically modified EPO
by carbamylation and does not bind to the erythropoietin receptor
(EPOR) and is thereby without haematopoietic side-effects. Despite
the lack of binding to EPOR, Lu AA24493 retains full cytoprotective
properties, demonstrating that Lu AA24493 mediates its beneficial
effects via a mechanism different from that of the classical EPOR.


Lundbeck contacts


Investors:                   Media:

Jacob Tolstrup               Mads Kronborg
Director, IR & Communication Media Relations
+45 36 43 30 79              +45 36 43 28 51

Palle Holm Olesen            Kasper Riis
Head of Investor Relations   Media Relations
+45 36 43 24 26              +45 36 43 28 33

Magnus Thorstholm Jensen
Investor Relations Officer
+45 36 43 38 16



About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international
pharmaceutical company highly committed to improve the quality of
life for people suffering from central nervous system (CNS)
disorders. For this purpose Lundbeck is engaged in the research and
development, production, marketing and sale of pharmaceuticals across
the world, targeted at disorders like depression and anxiety,
schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson's
diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,
and employs today over 5,500 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with CNS disorders.
In 2008, the company's revenue was DKK 11.3 billion (approximately
EUR 1.5 billion or USD 2.2 billion). For more information, please
visit www.lundbeck.com.

[1] Friedreich's Ataxia Fact Sheet; National Institute of
Neurological Disorders and Stroke